2026 is already promising to be another huge year for the advancement of New Approach Methodologies (NAMs). From the hotly anticipated EU Roadmap Towards Phasing Out Animal Testing to recent publications from US HHS leadership, the adoption of new methods to reduce and replace animal testing is not slowing down.
Of special interest is the growing list of programs and initiatives to validate and qualify NAMs for regulatory use. 2026 is likely to see the formal launch of UKCVAM, the announcements of the first VQN technologies, and (continuing its trend from 2025) a record number of technologies accepted into the FDA ISTAND program.
But, as these programs continue to accelerate, one critical mistake continues to plague NAMs developers as they seek to qualify their technologies: setting overly broad scopes for their “Context of Use” (COU) statements.
Where NAMs Developers Go Wrong
The function of a NAM’s COU is to precisely define how the technology’s data will be interpreted in regulatory review. For preclinical NAMs, this means the exact scientific question being answered in an IND or CTA submission.
I have had the pleasure of working with NAMs developers all over the world. The number one mistake made in the design of validation studies or submissions to qualification programs is a COU with an overly broad scope and poorly defined regulatory utility.
Examples of this mistake include:
- Describing how the NAM can help in drug discovery and lead selection in addition to or instead of preclinical evaluation
- Broadly discussing “safety” without describing how the technology improves regulator confidence in a specific safety assessment
- Describing utility in multiple unrelated applications, e.g. liver injury AND developmental toxicology AND Dose Range Finding
Most of my clients design their COU well in advance of initiating validation studies. Choosing a weak COU with incorrect scope can be an extremely expensive mistake. It can delay qualification by years and cost hundreds of thousands of dollars or more in reagents and overhead.
Imagine you were submitting a Biologics License Application for a monoclonal antibody against a novel target. In your application, would you include the fact that the new antibody could also be used as an off-the-shelf immunofluorescence reagent? Would you submit without defining what diseases it can treat? Would you seek approval for disease indications you didn’t test in clinical trials?
NO!
Why make the same mistake with your NAM?
Choose InnovApproach Consulting
At InnovApproach Consulting, we have firsthand experience navigating the full ISTAND qualification process, including developing and refining COUs for complex technologies. InnovApproach consultants were leaders in the first successful ISTAND submissions and helped define how a COU is integrated into the submission process.
If your team is developing a NAM and wants to ensure it is validated, qualified, and positioned for regulatory acceptance, contact InnovApproach Consulting. We’ll help you define a robust COU that lays the foundation for FDA recognition and long-term adoption.
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